Baseline Characteristics and Preliminary Responsiveness Classification Sample Clauses

Baseline Characteristics and Preliminary Responsiveness Classification. ‌ Of the 83 patients approached for study enrollment, 58 participated at baseline, 57 of which returned at month one for preliminary responsiveness classification. Thirty-two patients (55.2% of patients evaluated at baseline) were classified as preliminary responders. The remaining 25 patients (43.1% of patients evaluated at baseline) were classified as BH4 non-responders. Characteristics of patients at baseline and after one month BH4 therapy are displayed in Table 4-1. Mean plasma phenylalanine to tyrosine ratios were significantly different between the two groups at baseline (preliminary responders: 12.9 ± 9.8, non-responders: 20.4 ± 14.7; p=0.033) and after one month of BH4 therapy (preliminary responders: 6.4 ± 6.7, non- responders: 24.1 ± 15.9; p<0.0001). These differences were driven by plasma phenylalanine concentrations since plasma tyrosine concentrations did not differ between the groups at baseline (preliminary responders: 50.5 ± 15.5 μmol/L, non-responders: 52.1 ± 22.4; p=0.755) or month one (preliminary responders: 46.1 ± 21.4, non-responders: 48.4 ± 26.3; p=0.720).
Sample 1
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